The present invention relates to an apparatus used to fabricate an improved urine collection system for females who are incontinent or who are unable to use ordinary restroom facilities for extended periods of time.
While the use of absorbent materials, e.g. pads and garments, and catheterization represent two frequently used methods for treating urinary incontinence in females, neither is suited for extended periods of time or for females who while suffering from urinary incontinence otherwise lead normal active lifestyles, or who as a result of occupational circumstances cannot avail themselves of ordinary restroom facilities.
Absorbent garments, e.g. adult diapers, and pads are bulky, uncomfortable and hygienically offensive. The garments or pads must be frequently changed since urine trapped within the absorbent material provides a natural medium for bacterial growth and may cause both irritation and infection of sensitive skin tissue. Moreover, because the garment or pad does not prevent urine from contacting the vaginal and urethral openings or interior thereof, particularly when worn by one who is bedridden, there is a relatively high risk of serious internal infection.
As an alternative, indwelling catheterization, while preventing tissue maceration, is nonetheless irritating, if not painful and may result in urinary tract infections and bladder irritation. Moreover, it is unsuitable for the generally active female, i.e. those not confined to bed, but who nonetheless suffer from urinary incontinence or who are unable to use ordinary restroom facilities due to occupational circumstances.
A third and perhaps the most effectively balanced approach to urinary incontinency involves the use of a cup-like receptacle which is designed and positioned so as to surround substantially the uro-genital region and to collect urinary discharge. These receptacles are generally formed with an opening in the bottom which is connected to a drainage tube for transporting the urine to a suitable collection means, for example bag, generally secured to the leg of the patient. The receptacles may vary in size so as to surround the entire uro-genital area or fit within the uro-genital area (between the labia major) and surround essentially the urethral opening. The former, or large variety of receptacle, is generally held in place by means of a vaginal insert member affixed to the receptacle and a supporting garment. The latter, or smaller sized receptacle may either be held in place by the labia major alone or in combination with an attached vaginal insert member, an adhesive and/or support garment.
With either variety of receptacle, urine leakage is a major problem principally attributable to the inability of these devices to effect an essentially leak-resistant seal between the rim of the receptacle and the vulvar tissue which it contacts. All of the known urine receptacle devices are formed with generally smooth rim portions which do not mate well with the highly irregular and individual surface contours of the uro-genital tissue. While it is taught in the prior art to fabricate receptacles from materials such as ethyl methacrylate which becomes pliant at ordinary body temperatures and pressures so as to conform to the configuration of the user's body, in fact an optimum seal is not obtained and urine leakage continues to be a major problem along with the associated problems of vaginal infections and skin irritation.
These problems are substantially eliminated by the present invention which provides for a novel process of making a customized urine receptacle, the rim of which is fabricated to mate with the precise surface contours of the uro-genital tissue which it contacts.
Apart from the foregoing object of providing an essentially leak proof urine receptacle, it is a further object of the present invention to provide a urine collection device that does not utilize a vaginal insert member, but which may be easily and comfortably positioned with reference to the anterior wall of the vaginal opening, thereby permitting the simultaneous use of tampons during menstruation.
Still other objects, features and advantages of the present invention will be made apparent by the following description of preferred embodiments, drawings and claims.